Trial Outcomes & Findings for Race-Based Stress Trauma and Empowerment (NCT NCT05422638)

NCT ID: NCT05422638

Last Updated: 2025-12-29

Results Overview

Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: week 8
• Results posted on: 2025-12-29

Participant Flow

Participant milestones

Measure	Race-Based Stress Trauma & Empowerment (RBSTE) 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment	Present-Centered Wellness Group (PCWG) 8-week health promotion group focused on providing support and facilitating problem solving PCWG: 8-week health promotion group focused on providing support and facilitating problem solving
Overall Study STARTED	19	18
Overall Study COMPLETED	11	16
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Race-Based Stress Trauma & Empowerment (RBSTE) 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment	Present-Centered Wellness Group (PCWG) 8-week health promotion group focused on providing support and facilitating problem solving PCWG: 8-week health promotion group focused on providing support and facilitating problem solving
Overall Study Withdrawal by Subject	8	2

Baseline Characteristics

Race-Based Stress Trauma and Empowerment

Baseline characteristics by cohort

Measure	PCWG n=18 Participants 8-week health promotion group focused on providing support and facilitating problem solving PCWG: 8-week health promotion group focused on providing support and facilitating problem solving	Total n=37 Participants Total of all reporting groups	RBSTE n=19 Participants 8-week health promotion group focused on supporting coping with racism and empowerment RBSTE: 8-week health promotion group focused on supporting coping with racism and empowerment
Age, Continuous	46.9 years STANDARD_DEVIATION 14.6 • n=166 Participants	49.9 years STANDARD_DEVIATION 16.2 • n=167 Participants	56.2 years STANDARD_DEVIATION 17 • n=174 Participants
Sex: Female, Male Female	6 Participants n=166 Participants	12 Participants n=167 Participants	6 Participants n=174 Participants
Sex: Female, Male Male	12 Participants n=166 Participants	25 Participants n=167 Participants	13 Participants n=174 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=166 Participants	11 Participants n=167 Participants	5 Participants n=174 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=166 Participants	25 Participants n=167 Participants	13 Participants n=174 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=174 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=174 Participants
Race (NIH/OMB) Asian	1 Participants n=166 Participants	1 Participants n=167 Participants	0 Participants n=174 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=174 Participants
Race (NIH/OMB) Black or African American	12 Participants n=166 Participants	24 Participants n=167 Participants	12 Participants n=174 Participants
Race (NIH/OMB) White	5 Participants n=166 Participants	9 Participants n=167 Participants	4 Participants n=174 Participants
Race (NIH/OMB) More than one race	0 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=174 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=174 Participants
Region of Enrollment United States	18 participants n=166 Participants	37 participants n=167 Participants	19 participants n=174 Participants

PRIMARY outcome

Timeframe: week 0

Percentage of individuals enrolled out of total contacted

Outcome measures

Measure	Total Sample n=417 Participants All individuals approached about the study	PCWG Individuals who were enrolled in the study and assigned to PCWG
Enrollment Rate	8.87 percentage of individuals approached	—

PRIMARY outcome

Timeframe: week 1

Population: Participants did not know their condition until they arrived for the first session, so these data should not be interpreted by group.

Percentage of subjects who initiate any intervention among all enrolled subjects

Outcome measures

Measure	Total Sample n=19 Participants All individuals approached about the study	PCWG n=18 Participants Individuals who were enrolled in the study and assigned to PCWG
Initiation Rate	73.7 percentage of enrolled individuals	100 percentage of enrolled individuals

PRIMARY outcome

Timeframe: week 8

Population: Includes the 34 participants of the 37 enrolled who initiated intervention.

Percentage of subjects who complete 5 or 6 sessions of intervention among those who start the intervention

Outcome measures

Measure	Total Sample n=17 Participants All individuals approached about the study	PCWG n=17 Participants Individuals who were enrolled in the study and assigned to PCWG
Per Protocol Completion	64.7 percent inititiators completed 5+	94.1 percent inititiators completed 5+

PRIMARY outcome

Timeframe: week 8

Percentage of subjects who complete 5 or 6 sessions of intervention among all randomized subjects

Outcome measures

Measure	Total Sample n=19 Participants All individuals approached about the study	PCWG n=18 Participants Individuals who were enrolled in the study and assigned to PCWG
Intent-to-treat Completion	57.9 percentage of ITT completed 5+	88.9 percentage of ITT completed 5+

PRIMARY outcome

Timeframe: week 8

Population: Reduced numbers reflect missing data

Perceived acceptability of the interventions by participants AIM range 4-20 with greater scores indicating better acceptability

Outcome measures

Measure	Total Sample n=7 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Acceptability of Intervention Measure (AIM)	18.43 total score on a scale Standard Deviation 1.81	14.75 total score on a scale Standard Deviation 3.84

PRIMARY outcome

Timeframe: week 8

Population: Reduced numbers reflect missing data

Perceived appropriateness of the interventions by participants IAM range 4-20 with greater scores indicating better appropriateness

Outcome measures

Measure	Total Sample n=7 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Intervention Appropriateness Measure (IAM)	17.57 total score on a scale Standard Deviation 2.70	14.25 total score on a scale Standard Deviation 3.77

PRIMARY outcome

Timeframe: week 8

Population: Reduced numbers reflect missing data

Perceived feasibility of the interventions by participants FIM range 4-20 with greater scores indicating better feasibility

Outcome measures

Measure	Total Sample n=7 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Feasibility of Intervention Measure (FIM)	17.43 total score on a scale Standard Deviation 2.22	14.88 total score on a scale Standard Deviation 3.52

SECONDARY outcome

Timeframe: change from week 1 to week 8

Population: Reduced numbers reflect missing data

self-appraisal of physical well being range 1-5 with higher scores indicating better health

Outcome measures

Measure	Total Sample n=10 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Brief Personal Health Inventory (B-PHI): Physical Health	0.1 change score on a scale Standard Deviation 0.88	0.27 change score on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: change from week 1 to week 8

Population: Reduced numbers reflect missing data

self-appraisal of mental well being range 1-5 with higher scores indicating better mental health

Outcome measures

Measure	Total Sample n=10 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Brief Personal Health Inventory (B-PHI): Mental Health	0.97 change in score on a scale Standard Deviation 1.14	0.61 change in score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: change from week 1 to week 8

Population: Reduced numbers reflect missing data

self-appraisal of daily living range 1-5 with higher scores indicating better daily living

Outcome measures

Measure	Total Sample n=10 Participants All individuals approached about the study	PCWG n=8 Participants Individuals who were enrolled in the study and assigned to PCWG
Brief Personal Health Inventory (B-PHI): Daily Living	1.07 change in score on a scale Standard Deviation 0.99	0.43 change in score on a scale Standard Deviation 0.93

Adverse Events

Race-Based Stress Trauma & Empowerment (RBSTE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Present-Centered Wellness Group (PCWG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ariel J Lang, PhD, MPH

VA San Diego Healthcare System

Phone: 858-552-8585

Email: ariel.lang@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place